Zineryt powder and solvent for cutaneous solution

Home
Medicines
Zineryt powder and solvent for cutaneous solution

Company Products

Medicine Name	Active Ingredients
Medicine Name Dovobet Gel	Active Ingredients Betamethasone dipropionate, Calcipotriol monohydrate
Medicine Name Dovobet Ointment	Active Ingredients Betamethasone dipropionate, Calcipotriol monohydrate
Medicine Name Dovonex Cream	Active Ingredients Calcipotriol hydrate
Medicine Name Dovonex Ointment	Active Ingredients Calcipotriol
Medicine Name Dovonex Psoriasis 50 microgram/g ointment	Active Ingredients Calcipotriol
Medicine Name Enstilar Cutaneous Foam	Active Ingredients Betamethasone dipropionate, Calcipotriol monohydrate
Medicine Name Fucibet Cream	Active Ingredients Betamethasone Valerate, Fusidic Acid
Medicine Name Fucibet Lipid Cream	Active Ingredients Betamethasone Valerate, Fusidic Acid
Medicine Name Fucidin Cream	Active Ingredients Fusidic Acid
Medicine Name Fucidin H Cream	Active Ingredients Fusidic Acid Hemihydrate, Hydrocortisone Acetate
Medicine Name Fucidin Ointment	Active Ingredients Sodium Fusidate
Medicine Name Fucidin Suspension	Active Ingredients Fusidic Acid Hemihydrate
Medicine Name Fucidin Tablets	Active Ingredients Sodium Fusidate
Medicine Name innohep 10,000 IU in 0.5 ml syringe (Treatment in VTE)	Active Ingredients Tinzaparin sodium
Medicine Name innohep 10,000 IU/ml Solution for Injection (Prophylaxis and Haemodialysis)	Active Ingredients Tinzaparin sodium
Medicine Name innohep 12,000 IU in 0.6ml syringe (Treatment in VTE)	Active Ingredients Tinzaparin sodium
Medicine Name innohep 14,000 IU in 0.7 ml syringe (Treatment in VTE)	Active Ingredients Tinzaparin sodium
Medicine Name innohep 16,000 IU in 0.8ml syringe (Treatment in VTE)	Active Ingredients Tinzaparin sodium
Medicine Name innohep 18,000 IU in 0.9ml syringe (Treatment in VTE)	Active Ingredients Tinzaparin sodium
Medicine Name innohep 2,500 IU syringe (Prophylaxis and Haemodialysis)	Active Ingredients Tinzaparin sodium
Medicine Name Innohep 20,000 IU/ml Solution for Injection (Treatment in VTE)	Active Ingredients Tinzaparin sodium
Medicine Name innohep 3,500 IU syringe (Prophylaxis and Haemodialysis)	Active Ingredients Tinzaparin sodium
Medicine Name innohep 4,500 IU syringe (Prophylaxis and Haemodialysis)	Active Ingredients Tinzaparin sodium
Medicine Name innohep 8,000 IU in 0.4ml syringe (Treatment in VTE)	Active Ingredients Tinzaparin sodium
Medicine Name Kyntheum 210 mg Solution for Injection	Active Ingredients Brodalumab

Items Per Page :

1 - 0 of 38 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 10 July 2019 PIL

Reasons for updating

Improved presentation of PIL

Updated on 28 June 2019 PIL

Reasons for updating

Improved presentation of PIL

Updated on 9 January 2019 SmPC

Reasons for updating

Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Date of revision of the text has been updated - no other changes are made to the document.

Updated on 18 September 2018 PIL

Reasons for updating

Change to section 4 - possible side effects
Change to section 5 - how to store or dispose
Change to section 6 - manufacturer

Updated on 18 September 2018 SmPC

Reasons for updating

Change to section 1 - Name of medicinal product
Change to section 2 - Qualitative and quantitative composition
Change to section 4.4 - Special warnings and precautions for use
Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

1: The product name has been updated to Zineryt 40 mg + 12 mg powder and solvent for cutaneous solution.

2: the active substance name has been updated to zinc acetate dehydrate

4.4: The following PRAC warning has been added:

As with other macrolides, rare serious allergic reactions, including acute generalised exanthematous pustulosis (AGEP) have been reported. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted. Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued.

4.8: AGEP (acute generalised exanthematous pustulosis) has been added.

Updated on 24 July 2017 PIL

Reasons for updating

New PIL for new product

Updated on 24 July 2017 PIL

Reasons for updating

Improved presentation of PIL

Updated on 20 July 2017 SmPC

Reasons for updating

New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 20 July 2017 SmPC

Reasons for updating

Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Added street name and number to address of MAH

Updated on 29 June 2017 SmPC

Reasons for updating

Change to section 8 - Marketing authorisation number(s)
Change to section 10 - Date of revision of the text
Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 7 Change of MA Holder, from LEO Pharma A/S Denmark to LEO Laboratories, Dublin
Section 8 Change of MA Number - is now PA 0046/065/001
Section 10 Change of date of revision of text

Updated on 23 June 2017 PIL

Reasons for updating

Change to section 6 - marketing authorisation holder
Change to section 6 - date of revision

Updated on 3 February 2017 PIL

Reasons for updating

Correction of spelling/typing errors
Improved presentation of PIL

Updated on 31 October 2016 SmPC

Reasons for updating

Change to section 7 - Marketing authorisation holder
Change to section 8 - Marketing authorisation number(s)
Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to section 7 - Marketing authorisation holder
Change to section 8 - Marketing authorisation number
Change to section 10 - Date of revision of the text

Updated on 25 October 2016 PIL

Reasons for updating

Change to section 6 - marketing authorisation holder
Change to section 6 - date of revision

Updated on 2 July 2015 SmPC

Reasons for updating

Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8
Include HPRA e-mail address 'medsafety@hpra.ie' in Reporting of Suspected Adverse Reactions section.

Updated on 26 May 2015 SmPC

Reasons for updating

Change to Section 4.8 – Undesirable effects - how to report a side effect
Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The HPRA contact details for side-effect reporting have been updated to reflect the name change from IMB to HPRA
The date of revision is updated to May 2015

Updated on 21 May 2015 PIL

Reasons for updating

Change to date of revision
Addition of information on reporting a side effect.

Updated on 3 July 2013 SmPC

Reasons for updating

Change to improve clarity and readability

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

correction of spacing errors

Updated on 25 February 2013 PIL

Reasons for updating

Change of manufacturer

Updated on 12 October 2012 PIL

Reasons for updating

Change to MA holder contact details

Updated on 12 September 2012 PIL

Reasons for updating

Change to MA holder contact details

Updated on 16 August 2012 PIL

Reasons for updating

Change due to user-testing of patient information

Updated on 25 July 2012 SmPC

Reasons for updating

Change to section 7 - Marketing authorisation holder
Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change Detail

7 Marketing Authorisation Holder

Astellas Pharma Co Ltd

5 Waterside

Citywest Business Campus

Naas Road

Dublin 24

Ireland

Updated on 10 April 2012 PIL

Reasons for updating

Change to information about pregnancy or lactation
Improved electronic presentation

Updated on 7 December 2011 SmPC

Reasons for updating

Change to section 4.6 - Pregnancy and lactation
Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.6 Pregnancy and lactation

Human experience with oral erythromycin suggests that erythromycin can cause congenital malformations, such as cardiovascular malformations and pyloric stenosis, when administered during pregnancy.

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).

Zineryt® should not be used during pregnancy unless the clinical condition of the woman requires treatment with erythromycin.

It is recommended that the preparation should only be used with caution in lactating women who are breast feeding, and on areas away from the chest.

Updated on 20 August 2008 PIL

Reasons for updating

Change to improve clarity and readability
Change to date of revision

Updated on 15 February 2008 SmPC

Reasons for updating

Change to section 9 - Date of renewal of authorisation

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 2: (QUALITATIVE AND QUANTITATIVE COMPOSITION) “For excipients, see 6.1” was changed to read “For a full list of excipients, see section 6.1”

Section 6.3: (Shelf life) “2 years; 5 weeks after constitution” updated to read “Unopened: 2 years. Upon reconstitution: Use within 5 weeks “

Section 6.6: heading changed to read “Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product.”

Section 9: (DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION) date of last renewal updated to 17^th Dec 2007.

Section 10: (DATE OF REVISION OF THE TEXT) updated to December 2007.

Updated on 28 June 2006 SmPC

Reasons for updating

Change to section 7 - Marketing authorisation holder
Change to section 8 - MA number
Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 7: Marketing Authorisation Holder changed from Yamanouchi to Astellas Pharma Co. Ltd

Section 8: Marketing Authorisation Number changed to 1241/10/1

Section 10: Date of Revision of the Text changed to September 2005

Updated on 26 June 2006 PIL

Reasons for updating

New PIL for medicines.ie

Updated on 27 June 2003 SmPC

Reasons for updating

New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)